Update on US Phase 3 Pivotal Study
LANTERN Phase 3 pivotal study topline results expected within approximately six weeks.
- LANTERN study data points more than 350,000
- LANTERN study hospitals 18
- LANTERN study patients enrolled 5,188
- HCA Healthcare hospitals in US 14
- Canadian study sites 4
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Ondine Biomedical Inc. (AIM: OBI), a leader in light-activated antimicrobial therapies to prevent and treat hospital infections, today provides an update on its LANTERN Phase 3 pivotal study evaluating the Company's non-antibiotic nasal photodisinfection technology (branded as Steriwave® outside the US) to reduce the incidence of surgical site infections.
The Company has updated the expected timeline for release of topline results from the LANTERN Phase 3 study. Results are now expected within approximately six weeks, reflecting recent guidance from the Company's independent data management and statistical advisers regarding the time required to complete final data management, reconciliation and database lock activities. The revised timeline reflects the scale of the study and the normal process of finalising a high-quality analysis dataset and associated documentation in preparation for regulatory submission. The primary endpoint and success criteria remain unchanged.
Carolyn Cross, CEO of Ondine Biomedical, commented:
"The LANTERN study includes more than 350,000 data points sourced from 18 hospitals. Final database activities are progressing well, and we remain focused on reporting topline results as soon as possible. We are encouraged by the progress being made and believe results may be available ahead of the revised schedule. Meanwhile, Ondine continues to expand use of Steriwave in more hospitals and surgical specialities in markets where Steriwave is already approved."
The LANTERN (Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections) study is designed to evaluate the safety and efficacy of Ondine's nasal photodisinfection technology in reducing the rate of surgical site infections (SSIs). Conducted in collaboration with HCA Healthcare and select Canadian hospitals, the study enrolled 5,188 patients across 14 HCA Healthcare hospitals in the United States and four sites in Canada.
About Ondine Biomedical Inc.
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